The Easy Way to Research the FDA Using Keyword Search

The FDAzilla database contains information on every FDA inspected site since the year 2000. All of our 483s and warning letters -- over 25,000 documents -- are retyped, and keywords are tagged + categorized. In this video demonstration, we show you how to perform a keyword search of FDA warning letters in our system. To continue, either watch the video below or continue reading.

Food Industry | FDA Draft Guidance on Multiple Entity Registration Requirements

Do you own a food company that rents space to conduct any part of your business? Or, alternatively, do you own a facility that you rent to a food company? If you answered yes to either of the above questions, keep reading to find out the answer to one question you might have, “Do I need to register with the FDA?”

By | 2018-08-28T14:27:02+00:00 August 28th, 2018|CGMP, FDA Enforcement News, Food, Supplier Management|

A Bad 483 Could Cost a Company Millions

I spoke to a former VP of quality at the PDA/FDA Joint Regulatory Conference. He said one of his bad 483s probably cost him $5 million. And that’s cheap – that’s just a 483. What about a warning letter? There is an even greater magnitude of reputation damage, impact on new drug approvals, etc. This post describes the full scope and includes articles/case studies.

NASDA and FDA Work Together to Implement the Produce Safety Rule

Scott Gottlieb summarized the latest work the FDA is doing to implement the Produce Safety Rule (mandated by FSMA) in a letter addressed to NASDA. FDA and NASDA have worked toward ensuring objectivity and consistency for produce inspections. They have also been working on alternatives to the traditional 483 inspectional observation form. See the complete run-through of this crucial letter for the food industry.

By | 2018-08-18T01:45:03+00:00 August 16th, 2018|CGMP, FDA Enforcement News, Food, Form FDA 483, FSMA|